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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…
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In many testing laboratories, it can be necessary to qualify a new test method, instrument or lab itself with respect to one or more performance characteristics. One such key characteristic is bias, or mutual agreement of average test results run on the same material. A proposed ASTM standard will aid in the determination of bias equivalency. ASTM WK37659 , Guide for Testing for Bias Equivalency…
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For several years, ASTM International Committee E11 on Quality and Statistics has been preserving military sampling standards no longer supported by the U.S. Department of Defense. The latest ASTM standard to emerge from this program is ASTM E2819 , Practice for Single- and Multi-Level Continuous Sampling of a Stream of Product by Attributes Indexed by AQL. “The reason for preserving military…
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Interested parties are invited to join in the development of a new proposed standard being developed by ASTM International Committee E11 on Quality and Statistics . ASTM WK32565 , Guide for the Use of Non-Parametric Statistical Methods, is under the jurisdiction of Subcommittee E11.10 on Sampling/Statistics . According to Stephen Luko, statistician, Hamilton Sundstrand, Shared Engineering…, ASTM Committee E11 Next Meeting:, Oct. 26-28, 2011, ASTM International Headquarters, West Conshohocken, Pa., Technical Contact:, Stephen N. Luko, Hamilton Sunstrand, Shared Engineering Services, Windsor Locks, Conn., Phone: 860-654-3447; stephen.luko@hs.utc.com, ASTM Staff Contact:, Christine Sierk, Phone: 610-832-9728; csierk@astm.org Release #8978
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Measurement systems analysis is an important topic in statistics and quality for engineering, manufacturing, laboratory practice and business process applications. A new ASTM International standard, ASTM E2782 , Guide for Measurement Systems Analysis (MSA), covers many core issues of MSA. ASTM E2782 was developed by Subcommittee E11.20 on Test Method Evaluation and Quality Control, under the…
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With the proposed new standard, WK11023 , Practice for Life and Reliability Testing Based on the Exponential Distribution, ASTM International Committee E11 on Quality and Statistics is continuing its program of preserving U.S. government military standards on acceptance sampling. WK11023 is an adaptation of the DoD quality control and reliability handbook document H-108, Sampling Procedures and…
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While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537 , Guide for Application of Continuous Quality Verification to Pharmaceutical and…
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500 , Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on…
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Plastic pipe and components are used with low pressure oxygen and enriched air for a variety of applications, including medical and healthcare, agriculture (fish farming), welding and fabrication, waste water treatment and others. Despite this widespread use, there are currently no standards that help in the materials selection and design features of these systems. ASTM International Committee…
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A new ASTM International standard, E 2555 , Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and Reliability Inspection, represents the latest work of a task group that is converting a series of old U.S. Department of Defense standards into ASTM documents. The task group is part of Subcommittee E11.30 on Data Analysis, which is under the jurisdiction of ASTM…